Image-guided Breast Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)
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|ClinicalTrials.gov Identifier: NCT02057432|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : January 24, 2017
This research study is a pilot study designed to evaluate magnetic resonance imaging-guided therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the investigators are studying if it is possible to use intra-operative MRI to guide surgery. The therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite at Brigham and Women's Hospital.
The purpose of this study is to investigate if it is possible to perform the breast conserving surgery with the help of intra-operative magnetic resonance imaging in the advanced multimodality image guided operating suite. It is hoped that intra operative MRI may improve the surgeon's ability to know the exact margins of tumor. Currently, approximately 40% of women need to come back to the operating room and have the margins of the cancer re-excised.
|Condition or disease||Intervention/treatment||Phase|
|Stage I Breast Carcinoma Stage II Breast Carcinoma||Device: intra-operative MRI||Not Applicable|
The treatment being studied consists of standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated. The study includes the additional use of MRI to guide the removal of the cancer. The MRI uses powerful magnets linked to a computer to create detailed pictures of the breast. The purpose of the current study is to find out whether performing the intra-operative MRI is possible, safe and practical. As part of the study the participant will need to have tests to show that they are eligible to participate in the research study.If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.
- Wire localization with ultrasound, Mammogram or MRI in the non-palpable tumor is placed in the participant's breast. The presence of the wire in the tumor will then help guide the surgeon to the location of the tumor.
- The sentinel node biopsy or axillary dissection will be performed if indicated.
- Then the lumpectomy will be performed.
The participant will undergo an intra-operative MRI scan in the AMIGO.
---If the MRI images indicate there may be tumor behind, more tissue will be removed from the respective margins. No additional MRIs will be performed.
- Most of these operations are outpatient. However, the need to stay overnight may occur if the recovery from anesthesia is slow or if the participant underwent an axillary dissection.
Within six weeks after patient surgery. The participant will have the following procedures:
- History and physical exam
- Wound check
- The participant will also be informed of the final pathology, including margin status.The remainder of follow up will be as per standard of care after breast conserving surgery for breast cancer. The participant will be assessed by physical exam for possible complications and local recurrence. These visits will likely overlap with established oncology care team follow-up visits.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||A Pilot Study to Evaluate Image-guided Breast Conserving Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Intra-operative MRI
Images will be obtained both before and after intravenous bolus injection with subsequent dynamic imaging. Dynamic contrast enhancement maps will be created for evaluation of residual tumor. Images will be reformatted into three orthogonal planes as well as into a 3D model for surgical orientation. All imaging protocols using contrast, contrast enhancement maps and reformatting, as described above, which will be applied to the intra-operative MRI performed in the AMIGO suite are consistent with the standard MRI breast imaging at Brigham and Women's Hospital.
Device: intra-operative MRI
Patients will undergo an MRI during surgery.
- To demonstrate feasibility of using the intra-operative MRI for breast conserving surgery [ Time Frame: 2 Years ]
For the purpose of this pilot study, feasibility is defined as the ability to successfully complete the breast conserving operation in the
AMIGO suite. Feasibility must entail the following:
All necessary instruments for this operation are MRI compatible or are able to be used safely and then stored outside of the magnetic field when the intra-operative MRI is performed. The intra-operative MRI is performed without compromising the sterile operative field.
- Duration of the Lumpectomy and Imaging [ Time Frame: 2 Years ]To measure duration of the lumpectomy portion of the procedure, the duration of the imaging portion of the procedure, and time under anesthesia.
- Final Pathology Report and Intra-operative MRI Comparison [ Time Frame: 2 Years ]The intra-operative MRI images will be compared to final pathology report which is the gold standard. This objective is for the purpose of collecting preliminary data for planning a future study which will be adequately powered to show the sensitivity and true positives of the intraoperative MRI.
- Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation. [ Time Frame: 2 Years ]Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation.
- Volume of tissue removed on initial operation and on secondary operations if these were necessary. [ Time Frame: 2 Years ]Volume of tissue removed on initial operation and on secondary operations if these were necessary.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057432
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Mehra Golshan, MD||Dana Farber Cance Institute|